RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device. — FDA record Z-0532-2024

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 6, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Reason
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
Classification
Class II
Recalling firm
Encore Medical, LP
Quantity
146 units
Agency-reported status
Ongoing
Source record identifier
Z-0532-2024

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityPart Number: 508-32-204 UDI-DI Code: 00888912144391 Serial Numbers: 769P2825, 769P2846, 769P2893

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

U.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX, VA, and WA O.U.S.: None

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Dec 20, 2023
Recall initiation date
Sep 6, 2023
Center classification date
Dec 12, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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